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Evaluation of Schemes of Administration of Intravenous Ketamine in Depression

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ClinicalTrials.gov Identifier: NCT03742557
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Rodrigo Pérez Esparza, National Institute of Neurology and Neurosurgery, Mexico

Brief Summary:

Mexico, prevalence reported for major depressive disorder (MDD) is of 7.2%. It is currently in the top 5 causes of disability worldwide. One third of patients will not achieve remission after two treatments, being classified as treatment-resistant. In a neurochemical level, evidence shows dysregulation of the excitatory neurotransmitter Glutamate in patients with MDD. Chronic stress has been related to this dysregulation. Ketamine, has shown to regulate glutamatergic neurotransmission, and specially promote the release and production of neurotrophic factors key in the causes of MDD inhibited by glutamate dysregulation), and allow restoration of areas affected.

Clinical studies of ketamine in MDD have shown robust, durable , and rapid effects (during the first 4-24 hours), allowing a great opportunity for patients who do not achieve benefits from antidepressants or patients with suicidal ideation . These results have been reported in metaanalysis.

To our knowledge, there are no studies using Magnetic Resonance Spectroscopy, in areas related to MDD, after a series of ketamine administrations, which we think may show changes after this chronic administration and explain its antidepressant properties.

Goals: Provide clinical evidence of responseas well as a neurological basis or biomarker of response to a series of ketamine infusions.


Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Drug: Ketamine 50 MG/ML Injectable Solution, 0.5 mg/kg IV Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A double-blind randomized clinical trial (initially) will be performed, followed by an open-label trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Evaluation of Schemes of Administration of Intravenous Ketamine in Treatment-resistant Depression: Clinical-neuroimaging Correlation
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Ketamine

Ketamine 50 MG/ML - at a dose of 0.5 mg/kg IV diluted in 100cc of saline solution 0.9% over 40 minutes.

The intervention will be done twice weekly for 8 weeks.

Drug: Ketamine 50 MG/ML Injectable Solution, 0.5 mg/kg IV
Ketamine 0.5 mg/kg IV
Other Names:
  • Ketalar
  • Anesket

Placebo Comparator: Placebo
Saline solution 0.9% over 40 minutes. The intervention will be done twice weekly for 2 weeks, and then patients will receive intervention with ketamine as described above in the Active Comparator.
Drug: Ketamine 50 MG/ML Injectable Solution, 0.5 mg/kg IV
Ketamine 0.5 mg/kg IV
Other Names:
  • Ketalar
  • Anesket




Primary Outcome Measures :
  1. Depression Severity Hamilton Depression Rating Scale [ Time Frame: 4, 24, 72 hours, weekly up to 12 weeks or until relapse (Change from baseline to each measure) ]
    Depression Severity (10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe). Higher values represent a worse severity, but not necessarily outcome.

  2. Glutamate [ Time Frame: Basal, 10 minutes during intervention, 24 hours after, 4 weeks after (Change from baseline to each measure) ]
    Glutamate levels in the pgACC basal and after the last intervention with ketamine or placebo

  3. GABA [ Time Frame: Basal, 10 minutes during intervention, 24 hours after, 4 weeks after (Change from baseline to each measure) ]
    GABA levels in the pgACC basal and after the last intervention with ketamine or placebo

  4. Depression Severity Montgomery-Asberg Depression Rating Scale) [ Time Frame: 4, 24, 72 hours, weekly up to 12 weeks or until relapse (Change from baseline to each measure). Higher values represent a worse severity, but not necessarily outcome. ]
    Depression Severity (9-17 = mild, 18-34 = moderate, and ≥ 35 = severe)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 18-65 years
  2. MDD diagnosis as provided by DSM-5 criteria
  3. TRD as defined by failure to achieve response to two consecutive antidepressant therapies at an adequate dose and duration
  4. Patients approving inclusion by signing the informed consent

Exclusion Criteria:

  1. Comorbidity with other mental and neurological disorders (except generalized anxiety disorder)
  2. Substance use disorders at least 3 months prior to enrollment
  3. Evidence of structural abnormalities in basal MRI
  4. Pregnancy or lactation
  5. Hypersensitivity to ketamine
  6. Cardiac failure
  7. Personal history of psychosis
  8. First-degree relatives with history of psychosis
  9. Uncontrolled close-angle glaucoma
  10. Neurological disease (present)
  11. Uncontrolled Hypertension
  12. Contraindications for the realization of H1-MRS.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742557


Contacts
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Contact: Rodrigo Pérez-Esparza, M.D., M.Sc. +5256063822 ext 2085 dr.rodrigope@gmail.com
Contact: Camilo de la Fuente-Sandoval, M.D., Ph.D. +56063822 ext 5030 fcamilo@unam.mx

Locations
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Mexico
Instituto Nacional de Neurología y Neurocirugía (National Institute of Neurology and Neurosurgery) Recruiting
Mexico City, Tlalpan, Mexico, 14269
Contact: Rodrigo Pérez-Esparza, M.D. M.Sc    +5256063822 ext 2085    dr.rodrigope@gmail.com   
Contact: Camilo de la Fuente-Sandoval, M.D., Ph.D.    +5256063822 ext 5030    fcamilo@unam.mx   
Sponsors and Collaborators
National Institute of Neurology and Neurosurgery, Mexico
Investigators
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Principal Investigator: Rodrigo Pérez-Esparza, M.D., M.Sc. National Institute of Neurology and Neurosurgery

Publications of Results:
Espinosa-Aguilar C-A, Zamora-Olvera, Arronte-Rosales, Krug-Llamas, Olivares-Santos, Reyes-Morales, Tapia-Garcia, Garcia-Gonzalez, Doubova. Guía de práctica clínica para el diagnóstico y tratamiento de depresión en los adultos mayores. Salud Mental. 2007;30(6):69-80.
Heinze C. Guía clínica para el Manejo de la Depresión. In: Psiquiatría INd, ed. Guías Clínicas para la Atención de Trastornos Mentales. Mexico D.F.2010.

Other Publications:
American Psychiatric Association., American Psychiatric Association. DSM-5 Task Force. Diagnostic and statistical manual of mental disorders : DSM-5. 5th ed. Arlington, VA: American Psychiatric Association; 2013.
Pérez-Esparza R. Tratamiento farmacológico de la depresión: actualidades y futuras direcciones. Revista de la Facultad de Medicina. 2017;60(5):7-16.

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Responsible Party: Rodrigo Pérez Esparza, Medical Sciences Investigator, National Institute of Neurology and Neurosurgery, Mexico
ClinicalTrials.gov Identifier: NCT03742557     History of Changes
Other Study ID Numbers: 74/18
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Undecided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rodrigo Pérez Esparza, National Institute of Neurology and Neurosurgery, Mexico:
Depression
Ketamine
Treatment-Resistant
Magnetic Resonance Spectroscopy
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Pharmaceutical Solutions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action